INTERNATIONAL MEDICAL DEVICE REGULATION FORUM (EX GHTF)

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum. Furthermore, the Management Committee oversees Working Groups, which draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, consumer and patient groups.

The roles of IMDRF Chair and Secretariat rotate annually

The current members are:

Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the United States of America.

The World Health Organization (WHO) and the APEC LSIF Regulatory Harmonization Steering Committee are Official Observers. The Asian Harmonization Working Party (AHWP) and the Pan American Health Organization (PAHO) are IMDRF Affiliate Organizations.

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